Magnolo, Nina
Kingo, Külli
Laquer, Vivian
Browning, John
Reich, Adam
Szepietowski, Jacek C.
Keefe, Deborah
Papanastasiou, Philemon
Bao, Weibin
Forrer, Pascal
Patekar, Manmath
Funding for this research was provided by:
Novartis Pharma AG, Basel, Switzerland
Universitätsklinikum Münster
Article History
Accepted: 3 April 2022
First Online: 13 June 2022
Declarations
:
: This investigation was sponsored by Novartis Pharma AG, Basel, Switzerland. Nina Magnolo, Külli Kingo, Vivian Laquer, John Browning, Adam Reich, Jacek C. Szepietowski, Deborah Keefe, Philemon Papanastasiou, Weibin Bao, Pascal Forrer, Manmath Patekar
: N. Magnolo has been a principal investigator in studies performed by AbbVie, Almirall, Asana, Boehringer Ingelheim, BMS, Celgene, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Genentech, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Novartis, MSD, Pfizer, Regeneron, Sun Pharma, and UCB and is a consultant or speaker for AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly, LEO Pharma, Novartis, Pfizer, and UCB. K. Kingo has received fees for serving as an investigator in studies sponsored by Celgene, Merck, Mitsubishi Tanabe Pharma, Novartis, Regeneron Pharmaceuticals, and Sandoz. V. Laquer is an investigator for AbbVie, Amgen, Biofrontera, Cara Therapeutics, Celgene, ChemoCentryx, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Kiniksa, LEO Pharma, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB. J. Browning is an investigator for Amryt, Brickell Biotech, Celgene, ChemoCentryx, Eli Lilly, Incyte, Lenus, LEO Pharma, Mayne, Novartis, Pfizer, Regeneron, and Valeant; a consultant for Dermavant and LEO Pharma; and a speaker for Dermira, Regeneron, and Pfizer. JC. Szepietowski is an advisory board member for AbbVie, LEO Pharma, Novartis, Pierre Fabre, Menlo Theraputics, Sienna Biopharmaceuticans, and Trevi; a principal investigator for AbbVie, Novartis, Menlo Therapeutics, Trevi, Janssen, Merck, Regeneron, Amgen, Boehringer Ingelheim, Galapagos, Galderma, InflaRX, Kymab Ltd., Pfizer, UCB, Helm, and Incyte; and a speaker for AbbVie, Novartis, Janssen, Eli Lilly, Sanofi-Genzyme, Sunfarm, and Berlin-Chemie Mennarini. A. Reich is a principal investigator or subinvestigator in clinical trials sponsored by AbbVie, Drug Delivery Solutions Ltd, Galderma, Genentech, Janssen, Kymab Ltd, LEO Pharma, Menlo Therapeutics, MetrioPharm AG, MSD, Novartis, Pfizer, and Trevi Therapeutics and a consultant or speaker for AbbVie, Bioderma, Celgene, Chema-Elektromet, Eli Lilly, Galderma, Janssen, LEO Pharma, Medac, Menlo Therapeutics, Novartis, Pierre Fabre, Sandoz, and Trevi Therapeutics. D. Keefe and W. Bao are employees of Novartis Pharmaceuticals Corporation. P. Papanastasiou, P. Forrer and M. Patekar are employees of Novartis Pharma AG.
: The datasets generated and/or analyzed during the current study are not publicly available. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. These requests are reviewed and approved based on scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The data may be requested from the corresponding author of the manuscript.
: The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) and in compliance with all federal, local, or regional requirements. Institutional review board/Ethics Committees of each participating center approved the study protocol.
: A parent or legal guardian provided written informed consent, and the patient provided written assent, at screening before any assessment was performed. If patients reached age of consent (as per local law) during the study, they needed to also sign the corresponding study Informed Consent(s).
: All authors were involved in the drafting and critical review of the manuscript, and approved the final version for submission. NM, KK, VL, JB, AR, and JCS contributed to the design of the study and were involved in the acquisition of clinical data and participated as principal investigators in the clinical study from which data are reported in the manuscript. DK, PP, PF, and MP were involved in the conception, design, and clinical conduct of the trial. WB was involved in the analysis of the data in the manuscript. All authors were involved in the interpretation of data in the manuscript. All authors agreed to be accountable for all aspects of the work and attest to the accuracy and integrity of the work.